Study of Relvar Ellipta (fluticasone furoate/vilanterol) reports improvements in asthma patients versus standard care- GSK/Innoviva

GlaxoSmithKline and Innoviva announced positive results from the innovative Salford Lung Study (SLS) of Relvar Ellipta (fluticasone furoate/vilanterol) in asthma, carried out amongst 4,233 patients treated by their own General Practitioner in everyday clinical practice. This open-label, randomised study showed that significantly more asthma patients initiated on treatment with Relvar Ellipta 100/25mcg or 200/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved an improvement in their asthma control compared with patients who continued to take their usual care medicines. Usual care treatment included inhaled corticosteroids (ICS) administered as monotherapy or as ICS/LABA (Long Acting Beta Agonist) combinations.

For the primary effectiveness analysis, at 24 weeks a significantly higher percentage of patients with uncontrolled asthma and initiated on treatment with FF/VI achieved better control of their asthma (71%) measured by the Asthma Control Test (ACT), compared with patients continuing usual care treatment (56%). Improvement was defined as an ACT total score of at least 20 or an increase from baseline of at least 3. Statistically significant findings were also seen at 12, 40 and 52 weeks. In the study for the intent-to-treat (ITT) population, the incidence of serious adverse events (SAE) was the same in both arms (FF/VI 13% and usual care 13%). Pneumonia was a safety endpoint of special interest and a regulatory post-authorisation requirement of the European Medicines Agency (EMA).